Director, Skincare Medical Review Operations

2 weeks ago

Irvine, California, United States BioSpace, Inc. Full time
Job Details

Company Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.

Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.

For more information, visit Follow Allergan Aesthetics on LinkedIn.

Job Description

Position Summary


The Director of Skincare Medical Review leads and executes the development and implementation of the global medical operations strategy (Pharmacovigilance, Medical Information, Epidemiology and Medical Review) for SkinMedica skincare products (which include cosmetics, non-prescription drug products and consumer products) with focus on US, Canada, China, EU, and other major markets.

The position will provide hands-on support of activities including, but not limited to the following: safety surveillance; medical information; claims generation, advertising & promotional review of medical content, non-promotional review of publications and peer to peer communication, and labelling reviews for medical accuracy.

Key Duties / Responsibilities


Leads Global Medical Operations team, including Pharmacovigilance, Medical Information, and Medical Review, in executing all activities and deliverables that support pipeline and lifecycle management of existing skincare products.

o Adverse Event Reporting

o Medical Information

o Scientific Communications

o Scientific Education

o Product Development Support

o Medical review for promotional and non-promotional material

Additional projects, as requested

Qualifications

Minimum Requirements:
MD, BSN, PA/NP, RPh, PharmD, or other Advanced Skincare Clinician Required.

At least 10 years of Pharmacovigilance/Safety Surveillance or Medical Affairs experience

At least 10 years of cosmetic/personal care product industry, medical device industry or pharmaceutical industry

Knowledge of cosmetic and non-prescription drug products regulations, including but not limited to:

o The Food Drug and Cosmetic Act (FD&C)

o The Fair Packaging and Labeling Act (FPLA)

o Modernization of Cosmetic Regulations Act of 2022 (MoCRA)

o Good Manufacturing Practices (GMPs)

o Good Pharmacovigilance Practices (GPvP)

o Federal EPA and US state environmental regulations

o EU, Canada, APAC, LATAM and Africa international cosmetic regulations

Exhibits:
Strong communication skills, both verbal and written

Strong interpersonal skills and ability to work well in a matrixed organization

Ability to:
Manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities and challenges

Function in a controlled/regulated environment and handle restricted, confidential, private and personal information

Demonstrates:
Experience in establishing and maintaining effective relationships with management, peers, and customers

Note:

While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.

This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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